Positive final results from pharmacokinetic study (PK) with Infudopa SubC™ and Infudopa IntraV™ (IPO-001)

In a pharmacokinetic cross-over study, 18 patients with Parkinson ́s disease were assessed for 16 hours with respect to blood levels of levodopa when administered with levodopa plus carbidopa subcutaneously (Infudopa SubC™), intravenously (Infudopa IntraV™) or intestinally (Duodopa®/Duopa®).

The primary aims of the study, to show bioequivalence of Infudopa SubC™ and Duodopa®/Duopa® with respect to levodopa levels in plasma, and non-inferiority with respect to plasma level fluctuations, were all met. A comparison of levodopa levels following Infudopa SubC™ and Infudopa IntraV™, respectively, shows levodopa bioavailability for Infudopa SubC™ to be close to 100%. Effects on motor symptoms were the same for the three treatment groups. Local side effects of Infudopa SubC™ at the infusion site were mild or moderate.

“We are very much encouraged by these results that show that all the primary aims of the study were met,” says Björn Velin, CEO of Dizlin Pharmaceuticals. “The rapid increase in levodopa levels following subcutaneous administration, and the high concentrations obtained, indicate that Infudopa SubC™ may serve as a flexible monotherapy also for patients requiring high levodopa doses.”

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